Clinical data services
Perks of partnering with
Navitas Life Sciences
High on Quality
State of the art Infrastructure
Our unmatched experience
The data from clinical trials is extensive and it needs to be collected appropriately, streamlined, analyzed and presented in formats that are in accordance with regulatory compliance standards. With our expertise, we can deliver you greater efficiencies in terms of time, effort and cost, while ensuring the highest quality outcomes for your clinical trial. Our expert medical writing team includes physicians who have an in-depth knowledge about various therapeutic areas and will support your medical writing services from phase I to phase III and beyond to post authorization studies.
Clinical data management
Biostatistics and statistical programming
Wide range of reports
Clinical data standardization
We are with you all the way
Multiple platforms in clinical data management
Experts in clinical data standardization
Multiple submission capability in biostatistics and statistical programming
Platforms in medical writing
Leverage our high quality, timely and efficient clinical data services for your study
Successful outcomes using our clinical data services
End-to-End clinical data services drive successful outcomes
Clinical Data Services case study
Clinical data management
Clinical trials are adaptive and spread across multiple sites, making data integrity integral to the success of your trial. Efficient collecting, transferring, and managing of data during a clinical trial is critical for the smooth functioning of the drug development process.
Navitas Life Sciences ensures best in class Clinical Data Management services to enable effective study design, conduct, discrepancy management, close-out and regulatory compliance.
Select from our stellar Clinical Data Management services
Gain from our exceptional data integrity, collection, transfer and data management services
Flexible clinical data management services enable successful submission
Database delivery timelines shortened by 20% despite increase in the number of unique CRFs
by 300% (from 23 unique CRFs to 72 Unique CRFs)
Biostatistics & Statistical Programming
The Navitas Life Sciences biostatistics and statistical programming team consists of highly qualified and experienced statistical programmers. To understand your unique needs, our expert programmers will get in touch with your biostatisticians to give you exceptional analysis datasets and tables, listings and figures (TLF)as provided in your protocol or Statistical Analysis Plan (SAP).
Our onus has always been on delivery excellence which is possible by leveraging our domain experience in clinical trial data analytics and an in-depth knowledge of CDISC standards across multiple therapeutic areas. Navitas Life Sciences Biostatistics & Statistical Programming team will partner with you throughout the process of data acquisition, management and collation, delivering high quality content for successful regulatory submissions.
Your Partner for high quality Biostatistics and Statistical Programming
- Creation of safety and efficacy related TLGs and CDISC datasets
- Multiple submissions: IA, CSR, DMC, IB, PSUR, DSUR, RMP, ISS/ISE, Pooling
Benefit immensely from our biostatistics team for all your data analysis needs
Our Biostatistics and statistical programming model will help achieve success in your clinical Submission
Experienced Navitas Life Sciences’ SAS Programmers facilitated the client’s trial programmer role while enhancing the client productivity tool by including a GUI, incorporating authorized/restricted access, standardizing meta data, validating data and adding weekly reports and metrics
Clinical data standardization
Clinical trials are essential to identify the efficacy of newly developed drugs. However, pharma companies face a lot of problems like not having access to all levels of data, accuracy issues with derived analytics and an inability to deliver analytics rapidly and in an understandable manner. Our efficient process-based methodologies have been designed to create reusable source-target mappings for the generation of CDISC SDTM or ADaM datasets and submission ready documentation within a single process.
Our senior data standards consultants on our team excel at ensuring that the SDTM and/or ADaM is achieved efficiently, enabling you to adhere to regulatory compliance standards. A vital step in our process is to ensure that a single interpretation of the SDTM is identified, documented, managed, implemented and communicated consistently.
Precise data standardization methodologies
- Reusable source-to-target mapping specifications
- Optimized process to specify critical tabulation domain derived Variables
- Streamlined process to design and populate the Trial Design domains
- Efficient data transformation techniques
- Mapping of both ongoing and legacy data in compliance with CDISC SDTM
- Defining Sponsor-specific data standards in accordance with CDISC
- Shorter submission timelines
- Improved ability to perform efficient analysis
- Centralized metadata repository for end-to-end process efficiencies
Dedicated Data Standardization support to eliminate risk of rejection
Find out how complexities caused by unique data sets and aggressive timelines were handled effectively, with on time high quality submissions
Medical Writing is an integral part of clinical research, with our team delivering accurate, cost effective and high-quality documents to facilitate better drug development process. Our responsive medical writers will work with your team, transforming complex and diverse data into an evidence-based and precise account of your product’s clinical profile, with respect to treatment and patient safety.
The Right Partner for your Medical Writing Needs
- QbD design approach
- Medical Data Review using One Clinical Platform